FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
601–624 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583 · CAH
Ambu A/S
General Hospital · 342d
Cleared Apr 30, 2026
Bayesian Health Sepsis Flagging Device
K250680 · SAK
Bayesian Health, Inc.
Gastroenterology & Urology · 420d
Not Cleared Apr 30, 2026
Aurie System
DEN250023 · SHV
Cathbuddy, Inc.
Gastroenterology & Urology · 328d
Cleared Apr 29, 2026
YellowStar
K261094 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 27d
Cleared Apr 29, 2026
Break Wave
K261086 · LNS
Sonomotion, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 29, 2026
Echo Large Bore Introducer Sheath
K260606 · DYB
Echo Medical, LLC
Cardiovascular · 64d
Cleared Apr 29, 2026
ES-Series
K260589 · IYN
E-Scopics
Radiology · 68d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 29, 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C,...
K253914 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 142d
Cleared Apr 29, 2026
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885 · LPL
GEO MEDICAL CO., LTD.
Ophthalmic · 146d
Cleared Apr 29, 2026
DeepHealth ProstateAI
K253682 · QDQ
Quantib B.V.
Radiology · 159d
Cleared Apr 29, 2026
Aristotle 14 Guidewire
K253579 · MOF
Scientia Vascular, Inc.
Neurology · 163d
Cleared Apr 29, 2026
SCRIPT™ Implant System
K253401 · MAX
Globus Medical, Inc.
Orthopedic · 211d
Cleared Apr 29, 2026
F6S Full Face Mask (F6S)
K253166 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 215d
Cleared Apr 29, 2026
LEO Spinal System
K252542 · NKB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 260d
Cleared Apr 29, 2026
Paptizer 360
K252471 · QXQ
LiViliti Health Products Corporation
General Hospital · 266d
Cleared Apr 28, 2026
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581,...
K260260 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 90d
Cleared Apr 28, 2026
Ultra-Fast Warm
K260248 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 91d
Cleared Apr 28, 2026
Vacuum Pump (Model: AD-VPUM-500)
K260194 · MQG
Sheng Sheng Yi (Beijing) Technology...
Obstetrics & Gynecology · 96d
Cleared Apr 28, 2026
Manual Wheelchair (7101L, 7102LHD)
K260121 · IOR
Foshan Nanhai Hongchen Medical...
Physical Medicine · 103d
Cleared Apr 28, 2026
SAM 3.0 Multi-Hour Continuous Ultrasound Device
K260076 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 106d
Cleared Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 109d
Cleared Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · NKB
Medacta International S.A.
Orthopedic · 140d
Cleared Apr 28, 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · FYA
Cardinal Health 200, LLC
General Hospital · 211d